BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2222258 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11202
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED LOW DRAIN VOLUME ALARM WAS CONFIRMED. THE CAUSE WAS AIR IN THE PATIENT LINE, STEMMING FROM THE USE ERROR OF IMPROPER PRIME; THE PATIENT KEPT THE CLAMP CLOSED DURING PRIME, WHICH ALLOWED FOR AIR TO ENTER THE PATIENT LINE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING A LOW DRAIN VOLUME ALARM WITH THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THERE WAS AIR IN THE PATIENT LINE. SHE STATED SHE WAS TAUGHT TO LEAVE THE PATIENT LINE CLAMP CLOSED DURING PRIME AND SHE NEVER CHECKED IT FOR AIR OR TO MAKE SURE THE FLUID WAS ALL THE WAY TO THE TOP ONCE PRIMING WAS COMPLETE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SHE WOULD NEED TO START OVER WITH NEW SUPPLIES AND CONTACT THE NURSE ABOUT POSSIBLE AIR EXPOSURE. THE HP REFUSED TO START OVER WITH NEW SUPPLIES AND WANTED TO CONTINUE THERAPY WITH AIR IN THE LINE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED EVENT. THE HP CONFIRMED THERE WAS AIR IN THE PATIENT LINE BECAUSE SHE HAD CLAMPED OFF THE PATIENT LINE DURING PRIME. THE HP STATED SHE NOTIFIED HER NURSE OF THE ERROR WHO ADVISED HER TO KEEP THE PATIENT LINE CLAMP OPEN DURING PRIME. THE HP ADVISED THAT SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR HOMECHOICE